Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


'Refuse-To-Accept' Policy Outlined For De Novos In New US FDA Draft Guidance

Executive Summary

Following a user fee deal that will subject de novo applications to performance goals and user-fee payments, US FDA has proposed a guidance that attempts to explain its process for considering when to accept, and when not to accept, a de novo submission for review.


Related Content

Minding The Middle: FDA Fleshes Out De Novo Regs As The Program Expands
US Approvals Analysis: Original PMA Slowdown, De Novo Upswing Among Recent Trends
De Novo Policies Clarified In Final Guidance
US FDA Fees To Spike In FY 2018, But Small Firms Get Breaks





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts